Merck & Co., Inc. has announced the trademark Janumet for MK-0431A, the company's investigational oral medicine combining sitagliptin phosphate with metformin for type 2 diabetes.
Janumet is designed to provide an additional treatment option for patients who need more than one oral agent to help control their blood sugar and is currently under standard review by the US Food and Drug Administration (FDA). Merck expects FDA action on the New Drug Application (NDA) by the end of March 2007. The company is also moving forward as planned with regulatory filings in countries outside the United States.
Data supporting Janumet were previously disclosed earlier this year at the 66th annual meeting of the American Diabetes Association (ADA) as well as the 42nd annual meeting of the European Association for the Study of Diabetes (EASD).
Data were presented at the ADA included a 24-week, double-blind study of patients who had inadequate glycemic control with metformin (at least 1,500 mg daily). In this study, sitagliptin phosphate 100 mg once daily added to patients inadequately controlled on metformin led to a significant additional mean reduction in A1C of 0.7 per cent compared with placebo.
The concurrent administration of sitagliptin phosphate with metformin was generally well tolerated, with no increased incidence of hypoglycemia or gastrointestinal adverse events compared with the placebo arm of the study. Body weight changes were similar between the treatment groups.
Data presented at the EASD meeting demonstrated a significant mean placebo-subtracted reduction in A1C of 2.1 percent from a mean baseline A1C of 8.8 per cent with sitagliptin phosphate 50 mg twice daily and metformin 1,000 mg twice daily in patients as initial therapy. This study included another arm with sitagliptin phosphate and a lower dose of metformin and also monotherapy and placebo arms. Full results from this study for Janumet plus other data supporting sitagliptin phosphate will be presented next week at the 19th World Diabetes Congress in Cape Town, South Africa.
In the study presented at EASD, simultaneous treatment with sitagliptin phosphate and metformin was generally well tolerated and showed no meaningful differences in tolerability compared to metformin alone. Side effects of simultaneous treatment with sitagliptin phosphate 50 mg twice daily and metformin 1,000 mg twice daily compared to metformin 1,000 mg twice daily alone included diarrhoea (9 per cent vs. 10 percent, respectively), nausea (6 per cent vs. 8 per cent, respectively), abdominal pain/discomfort (3 per cent vs. 5 per cent, respectively) and vomiting (3 percent vs. 1 per cent, respectively).